Biofreeze Professional
- Product NDC
- 68071-4325
- 11-digit product format
- 680714325
- Labeler code
- 68071
- Product ID
- 68071-4325_1a3dd23e-1c5a-9d41-e063-6394a90a3455
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL, UNSPECIFIED FORM
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- M004
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-06-03
- Substance
- MENTHOL, UNSPECIFIED FORM
- Active strength
- 50 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 68071-4325-4 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 68071-4325-4 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 68071-4325-4 | 1332a3947898… | d4bfe170f9cd… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Biofreeze Professional
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL, UNSPECIFIED FORM | 50 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 66ff9726-20da-688a-e053-2a91aa0a59ac | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2024-06-07 | Biofreeze Professional Gel |
| 2023-01-30 | Biofreeze Professional Gel |
| 2021-02-16 | Biofreeze Professional Gel |
| 2021-01-29 | Biofreeze Professional Gel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-4325-4 | Biofreeze Professional | 120 mL in 1 TUBE | GEL | 120 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-4325 | BIOFREEZE PROFESSIONAL (MENTHOL, UNSPECIFIED FORM) GEL [NUCARE PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240608_66ff9726-20da-688a-e053-2a91aa0a59ac.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| First Aid Antibiotic plus Burn Relief | BACITRACINZINC,NEOMYCINSULFATE,POLYMXINBSULFATE,PRAMOXINEHCI | Trifecta Pharmaceuticals USA LLC | 048871e2-c917-292d-e063-6394a90af130 | 2024-12-18 | Warnings | M004 |
| TheraCare Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Veridian Healthcare | 0c3fc798-9a97-5316-e063-6394a90a6830 | 2024-12-18 | Warnings | M004 |
| Bacitracin Zinc | BACITRACIN ZINC | Rugby Laboratories | ac3c9897-c812-1360-e053-2a95a90ad591 | 2024-12-17 | Warnings | M004 |
| Major Bacitracin | BACITRACIN ZINC | Major Pharmaceuticals | a23ce772-7078-0a4b-e053-2995a90aff0d | 2024-12-17 | Warnings | M004 |
| Bacitracin Zinc | BACITRACIN ZINC | Trifecta Pharmaceuticals USA LLC | eea0d90c-914b-2624-e053-2a95a90a34c9 | 2024-12-13 | Warnings | M004 |
| OP First Aid Series TRIPLE ANTIBIOTIC | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Nantong Health & Beyond Hygienic Products Inc. | cadebf07-dd48-4855-8296-7a91e28d7123 | 2024-12-05 | Warnings | M004 |
| triple antibiotic and pain relief | BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | CVS Pharmacy | f0864d78-23e6-4e6c-bc67-7ba3e6dd862c | 2024-12-03 | Warnings | M004 |
| triple antibiotic | BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | Publix Super Markets Inc | 330c7b7a-d0d1-42dc-b8f7-9c96aeaf69f9 | 2024-11-25 | Warnings | M004 |
| WinCo Maximum Strength Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE | WinCo Foods, LLC | 01b03c7e-6c4e-43aa-8480-aff1c2688f7f | 2024-11-21 | Warnings | M004 |
| WinCo Original Strength Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | WinCo Foods, LLC | e364b623-6e20-4894-8d4c-5c739be78f86 | 2024-11-21 | Warnings | M004 |
| Winco Bacitracin Zinc | BACITRACIN ZINC | WinCo Foods, LLC | dcdf647f-fa32-4b72-b714-a77e8e332358 | 2024-11-21 | Warnings | M004 |
| Walgreens Multi-Antibiotic with Pain Relief Cream | POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE | Walgreens Company | f4feccc3-ac25-4d8a-9b68-9a24f755524a | 2024-11-20 | Warnings | M004 |
| Walgreens Kids Multi-Antibiotic with Pain Relief Cream | POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE | Walgreens Company | fbc364d7-d8b8-43f5-99cc-290438f3982b | 2024-11-20 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Acme United Corporation | f9a48f73-aa12-cf68-e053-6294a90a8e53 | 2024-11-19 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Acme United Corporation | e55cbf7e-c955-7f1a-e053-2a95a90a3f28 | 2024-11-19 | Warnings | M004 |
| First Aid Only Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Acme United Corporation | f4eba34c-ce31-3004-e053-2995a90a245b | 2024-11-19 | Warnings | M004 |
| First Aid Only Neomycin Antibiotic | NEOMYCIN SULFATE | Acme United Corporation | c651e98e-aabe-de46-e053-2a95a90a6307 | 2024-11-19 | Warnings | M004 |
| Neosporin Original | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Kenvue Brands LLC | f07d3bca-4312-46ed-b0c4-f886c01bd095 | 2024-11-14 | Warnings | M004 |
| Polysporin First Aid Antibiotic | BACITRACIN ZINC AND POLYMYXIN B SULFATE | Kenvue Brands LLC | e0fcf83e-a374-4fc0-a629-873033054392 | 2024-11-14 | Warnings | M004 |
| Neosporin Pain Itch Scar | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | 55392c48-b5d8-44cd-8c10-6d8668349848 | 2024-11-13 | Warnings | M004 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1794892 | BIOFREEZE 5 % Topical Gel | PSN | 66ff9726-20da-688a-e053-2a91aa0a59ac | 6 |
| 415975 | menthol 5 % Topical Gel | PSN | 66ff9726-20da-688a-e053-2a91aa0a59ac | 6 |
| 1794892 | menthol 0.05 MG/MG Topical Gel [Biofreeze] | SBD | 66ff9726-20da-688a-e053-2a91aa0a59ac | 6 |
| 415975 | menthol 0.05 MG/MG Topical Gel | SCD | 66ff9726-20da-688a-e053-2a91aa0a59ac | 6 |
| 1794892 | Biofreeze 5 % Topical Gel | SY | 66ff9726-20da-688a-e053-2a91aa0a59ac | 6 |
| 415975 | menthol 5 % Topical Gel | SY | 66ff9726-20da-688a-e053-2a91aa0a59ac | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-4325-4 | 68071432504 | 120 mL in 1 TUBE (68071-4325-4) | 120 ml | 2018-03-09 | 0000-00-00 | No | No | Current |